Last updated on May 2018

A Phase I Study of Photodynamic Therapy (PDT) for High-grade Anal Dysplasia and Microinvasive Anal Cancer

Brief description of study

This is a phase I dose escalation study of photodynamic therapy (PDT) for the treatment of patients with pre-malignant tumors and superficial microinvasive disease of the anal canal and/or perianal skin. All subjects (a maximum of 12) will be given the photosensitizer Gliolan orally followed by the administration of red light (629-635 nm) to the tumor from a laser. The dose of Gliolan will be 40 mg/kg administered approximately 4-6 hours before light administration. There will be two levels of light dose: 50 and 100 J/cm2, 3-6 patients in each. Patients will be observed for 30 days for the development of DLT. Patients will be followed up for 24 months for additional toxicity and efficacy data collection.

Clinical Study Identifier: NCT02698293

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Edgar Ben-Josef, MD

Abramson Cancer Center of the University of Pennsylvania
Philadelphia, PA United States
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Recruitment Status: Open

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